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目的观察重组人干扰素β1b(rhIFNβ1b)治疗复发缓解型多发性硬化症(RRMS)的安全性及临床疗效。方法选择20名健康志愿者,分为1.5、3、6和9MIU4个剂量组,每天按剂量皮下注射1次rhIFNβ1b,连续注射8d,观察药物的安全性、耐受性和药代动力学。选择101例RRMS患者,随机分为观察组(52例)和对照组(49例),每周3次分别注射6MIU的rhIFNβ1b和25mg人血白蛋白,用药1年后,2组均注射6MIU的rhIFNβ1b,每周3次,用药1年。定期随访并进行各项指标及核磁共振成像(MRI)检查,观察药物的临床疗效,同时进一步观察安全性。结果安全性观察显示,rhIFNβ1b在9MIU剂量范围内耐受性良好。观察组和对照组分别注射rhIFNβ1b后,可显著减少RRMS患者头部与脊髓中病灶数量或缩小病灶体积,并显著降低复发率,且随着用药时间的延长,效果更加明显。结论rhIFNβ1b安全性和耐受性良好,临床影象学评价疗效显著。
Objective To observe the safety and clinical efficacy of recombinant human interferon β1b (rhIFNβ1b) in the treatment of recurrent remitting multiple sclerosis (RRMS). Methods Twenty healthy volunteers were divided into four groups of 1.5, 3, 6 and 9 MIU. The mice were injected subcutaneously with rhIFNβ1b once daily for 8 days. The safety, tolerability and pharmacokinetics of the drug were observed. A total of 101 patients with RRMS were randomly divided into observation group (n = 52) and control group (n = 49). 6MIU of rhIFNβ1b and 25mg of human serum albumin were injected three times a week. One year later, rhIFNβ1b, 3 times a week, medication for 1 year. Regular follow-up and carried out various indicators and MRI examination to observe the clinical efficacy of drugs, while further observation of safety. Results Safety observations showed that rhIFNβ1b was well tolerated in the 9MIU dose range. After injection of rhIFNβ1b, the observation group and the control group could significantly reduce the number of lesion and lesion volume in the head and spinal cord of RRMS patients and significantly reduce the recurrence rate, and the effect was more obvious with the extension of the medication time. Conclusion rhIFNβ1b is safe and well tolerated, and clinical imaging evaluation is effective.